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Manage processing, follow-up, analysis and regulatory reporting of AEs and SAEs for marketed and investigational human and veterinary products
Perform medical evaluation of safety cases in compliance with global regulatory requirements
Prepare aggregate safety reports including PBRERs, PSURs, Addendum PSURs, ACOs, PADERs and PSUR line listings
Perform quality checks of aggregate safety reports
Conduct signal detection related analyses including cumulative and issue-based event analyses
Ensure compliance with client conventions, SOPs and global pharmacovigilance guidelines
Maintain accuracy, consistency and timelines for all safety deliverables
Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics)
BDS / B.V.Sc. / M.V.Sc.
Pharmacovigilance industry experience preferred
Strong knowledge of medical terminology and pharmacovigilance processes
Excellent written and spoken English communication skills
Ability to prepare concise and accurate medical synopses and narratives
Ability to evaluate safety data independently and draw conclusions
Proficiency in MS Word, Excel, PowerPoint and web-based safety applications
Strong analytical and documentation skills
Continuum is a leading contract research organization providing services in Pharmacovigilance, Regulatory, Evidence Evaluation and Technology
The organization employs scientists and physicians to support global safety and regulatory operations